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Health Highlights: Nov. 16, 2018
Posted yesterday in Medical
Here are some of the latest health and medical news developments, compiled by the editors of HealthDay: More Raw Turkey Products Recalled More than 91,000 pounds of raw turkey products from Jennie-O Turkey Store Sales, LLC have been recalled after some products tested positive for a salmonella strain associated with an outbreak linked to raw turkey products, the U.S. Department of Agriculture's Food Safety and... Read more
For Kids' Sports, Diversification Is Best
Posted today in Medical
SATURDAY, Nov. 17, 2018 -- If your kid is highly skilled at hockey but wants to try basketball, new research suggests you shouldn't worry about whether that might cost your child a college scholarship. Researchers surveyed 91 professional and collegiate ice hockey players and found they tended to play multiple sports as children, and only started to focus solely on hockey at about age 14. "In many sports, there's a... Read more
FDA Approves Adcetris (brentuximab vedotin) in Combination with Chemotherapy for Adults with Previously Untreated Systemic Anaplastic Large Cell Lymphoma or Other CD30-Expressing Peripheral T-Cell Lymphomas
Posted today in New Drug Approvals
BOTHELL, Wash.--(BUSINESS WIRE)--Nov. 16, 2018-- Seattle Genetics, Inc. (Nasdaq:SGEN) today announced a new approval for Adcetris (brentuximab vedotin) in combination with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone) from the U.S. Food and Drug Administration (FDA) for adults with previously untreated systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T-cell lymphomas... Read more
AAP Updates Management of Sport-Related Concussion
Posted today in News for Health Professionals
FRIDAY, Nov. 14, 2018 -- Recommendations have been developed for the diagnosis and management of pediatric sport-related concussion (SRC), according to a clinical report published online Nov. 12 in Pediatrics. Mark E. Halstead, M.D., from the Washington University School of Medicine in St. Louis, and colleagues updated the 2010 American Academy of Pediatrics clinical report on the current state of knowledge and... Read more
Epinephrine Personal Autoinjectors Cost-Effective at $24
Posted today in News for Health Professionals
FRIDAY, Nov. 16, 2018 -- In a simulation of children with peanut allergy, epinephrine personal autoinjectors are cost-effective at $24, according to a study published online Nov. 16 in JAMA Network Open. Marcus Shaker, M.D., from the Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire, and Matthew Greenhawt, M.D., from the University of Colorado School of Medicine in Aurora, assessed cost ceilings for... Read more
CDC: Increase Seen in Salmonella Illnesses From Ground Beef
Posted today in News for Health Professionals
FRIDAY, Nov. 16, 2018 -- There have been 126 more cases of illness added to an investigation into a Salmonella outbreak linked to recalled ground beef products from JBS Tolleson Inc., bringing the total to 246 cases in 25 states, the U.S. Centers for Disease Control and Prevention says. Illnesses began between Aug. 5, 2018, and Oct. 16, 2018, and 59 people have been hospitalized. No deaths have been reported, the... Read more
Burden of Liver Cancer Rising in Medicare Patients
Posted today in News for Health Professionals
FRIDAY, Nov. 16, 2018 -- Both hospitalizations and deaths are increasing among Medicare recipients with liver cancer, according to a study presented at The Liver Meeting, the annual meeting of the American Association for the Study of Liver Diseases, held from Nov. 9 to 13 in San Francisco. Omer Shahab, M.D., from Inova Fairfax Hospital in Falls Church, Virginia, and colleagues used ICD-9 codes among a random sample... Read more
Climate Change Expected to Lead to Rise in Lyme Disease
Posted today in News for Health Professionals
FRIDAY, Nov. 16, 2018 -- Rising temperatures are expected to increase the number of cases of Lyme disease in the United States by more than 20 percent by mid-century, according to a study published online Oct. 24 in the Canadian Journal of Infectious Diseases and Medical Microbiology. Igor Dumic, M.D., from the Mayo Clinic in Rochester, Minnesota, and Edson Severnini, Ph.D., from Carnegie Mellon University in... Read more
Vapers May Prompt Smokers to Quit: Study
Posted today in Medical
FRIDAY, Nov. 16, 2018 -- Could vapers be a good influence on smokers? New research suggests that's so: Cigarette smokers who spent more time with people who used electronic cigarettes were more likely to try quitting smoking. The study included more than 13,000 smokers in England. Of those, nearly 26 percent said they regularly spent time with e-cigarette users. Among that group, about 32 percent made an attempt to... Read more
AHA: Warm, Wet Weather Linked to Better Outcomes for Stroke Survivors
Posted yesterday in Medical
FRIDAY, Nov. 16, 2018 (American Heart Association) -- Rainy days may bring a lot more than relief from summer heat -- they also are connected to better survival chances and overall outlook for stroke survivors, according to a new study. Researchers examining the connection between strokes and seasonal weather in the United States found that hospital admissions for ischemic strokes, those caused by blood clots, went... Read more
Under New Plan, FDA Hopes to Cut Use of Dogs in Veterinary Drug Trials
Posted yesterday in Medical
FRIDAY, Nov. 16, 2018 -- As part of a new effort to cut the use of dogs in drug trials, the U.S. Food and Drug Administration on Friday launched an initiative to keep canines out of studies for certain veterinary medicines. The project is aimed at "bioequivalence" trials -- studies conducted to test whether a new generic version of a drug is equivalent in effectiveness and safety to an existing medicine. Often,... Read more
Lilly Submits New Drug Application to the FDA for Lasmiditan for Acute Treatment of Migraine
Posted 3 days ago in New Drug Applications
INDIANAPOLIS, Nov. 14, 2018 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) has announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for lasmiditan for the acute treatment of migraine with or without aura in adults. Lasmiditan is an investigational, oral, centrally-penetrant, selective serotonin 5-HT1F agonist that is structurally and mechanistically distinct... Read more
FDA Approves Yupelri (revefenacin) for Chronic Obstructive Pulmonary Disease (COPD)
Posted 7 days ago in New Drug Approvals
DUBLIN, Ireland, HERTFORDSHIRE, England and PITTSBURGH, Nov. 9, 2018 /PRNewswire/ -- Theravance Biopharma, Inc. (NASDAQ: TBPH) ("Theravance Biopharma") and Mylan N.V. (NASDAQ: MYL) ("Mylan") today announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Yupelri (revefenacin) inhalation solution for the maintenance treatment of patients with... Read more
FDA Approves Keytruda (pembrolizumab) for the Treatment of Patients with Hepatocellular Carcinoma (HCC) Who Have Been Previously Treated with Sorafenib
Posted 8 days ago in New Drug Approvals
KENILWORTH, N.J.--(BUSINESS WIRE) November 9, 2018 --Merck (NYSE:MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib. This indication is approved under accelerated approval based... Read more
FDA Approves Newly Formulated OTC Primatene Mist (epinephrine) to Treat Mild Asthma
Posted 9 days ago in New Drug Approvals
RANCHO CUCAMONGA, Calif., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Amphastar Pharmaceuticals, Inc., (NASDAQ: AMPH) announced today that the U.S. Food and Drug Administration (FDA) granted approval of its New Drug Application (NDA) for Primatene Mist (epinephrine inhalation aerosol bronchodilator suspension), which is delivered by a metered dose inhaler (MDI) with a non-chlorofluorocarbon (CFC) propellant. Primatene Mist is... Read more
Bausch Health Announces U.S. Launch of Bryhali (halobetasol propionate) Lotion, 0.01%, for Plaque Psoriasis In Adults
Posted 9 days ago in New Drug Approvals
LAVAL, Quebec, Nov. 7, 2018 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, today announced it expects to start distribution of Bryhali (halobetsasol propionate) Lotion, 0.01%, to U.S. wholesale pharmaceutical distributors later this month. The company received final approval from the... Read more
Trevena Receives Complete Response Letter for Oliceridine from FDA
Posted 2 weeks ago in New Drug Applications
November 2, 2018 -- Trevena, Inc. (NASDAQ: TRVN) today announced the Company has received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for oliceridine. “While we are disappointed with FDA’s decision, we continue to believe in the strength of the data and the ultimate approvability of oliceridine,” said Carrie L. Bourdow,... Read more
Sage Therapeutics Announces FDA Advisory Committee Votes 17-1 in Support of Benefit-Risk Profile of Zulresso (brexanolone) Injection for Treatment of Postpartum Depression
Posted 2 weeks ago in New Drug Applications
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 2, 2018-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) and Drug Safety and Risk Management Advisory Committee (DSaRM) jointly voted (17 yes,... Read more
Alkermes Reports on Outcome of FDA Advisory Committee Meeting on ALKS 5461 for the Adjunctive Treatment of Major Depressive Disorder
Posted 2 weeks ago in New Drug Applications
DUBLIN, Nov. 1, 2018 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee, appointed by the U.S. Food and Drug Administration (FDA), met to review the company's New Drug Application (NDA) for ALKS 5461. The committee jointly voted that the benefit-risk profile was not adequate to support... Read more
Heron Announces FDA Submission of HTX-011 NDA for Postoperative Pain Management
Posted 2 weeks ago in New Drug Applications
SAN DIEGO, Oct. 31, 2018 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, today announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for HTX-011. HTX-011 is an investigational,... Read more
Attenua Announces First Patient Treated in Phase 2 Clinical Trial in Chronic Cough with Bradanicline
Posted 2 days ago in Clinical Trials
San Mateo, Calif, Nov 14, 2018 – Attenua, Inc., a clinical-stage biopharmaceutical company focused on developing novel medicines to treat cough, today announced that the first patient has been treated in a Phase 2 clinical trial in chronic cough with bradanicline (formerly known as ATA-101), its lead compound. “Within just six months of our initial Series A funding, Attenua has successfully filed an... Read more
Entasis Therapeutics Announces Zoliflodacin Phase 2 Results Published in The New England Journal of Medicine
Posted 9 days ago in Clinical Trials
WALTHAM, Mass., Nov. 07, 2018 (GLOBE NEWSWIRE) -- Entasis Therapeutics (NASDAQ: ETTX), a clinical-stage biopharmaceutical company focused on the discovery and development of novel antibacterial products, announced that The New England journal of Medicine (NEJM) published results from a Phase 2 clinical trial evaluating the safety and efficacy of zoliflodacin in patients with uncomplicated gonorrhea. Zoliflodacin... Read more
Janssen Reports Positive Topline Results for FLAIR Phase 3 Study of a Novel, Long Acting Injectable Two-Drug Regimen for the treatment of HIV-1
Posted 2 weeks ago in Clinical Trials
CORK, IRELAND, October 31, 2018 – The Janssen Pharmaceutical Companies of Johnson & Johnson today confirmed positive topline results from the global, Phase 3 FLAIR (First Long-Acting Injectable Regimen) study of a long-acting, injectable two-drug regimen (2DR) for the treatment of HIV. The study, conducted by ViiV Healthcare, showed long-acting rilpivirine and cabotegravir, injected once a month, had... Read more
Two-year data for Novartis brolucizumab reaffirm superiority versus aflibercept in reducing retinal fluid in patients with nAMD
Posted 2 weeks ago in Clinical Trials
Basel, 27 October, 2018 - Novartis announced additional brolucizumab Phase III results from year two that reaffirmed its positive year one findings. Brolucizumab met its primary endpoint of non-inferiority versus aflibercept in best corrected visual acuity (BCVA) and exhibited superiority in key retinal outcomes at year one (48 weeks)[1],[2]. Secondary endpoints at year two (96 weeks) reaffirmed superiority of... Read more
New STAIRWAY Study Data Shows Potential for Extended Durability With Faricimab in Wet Age-Related Macular Degeneration (AMD)
Posted 2 weeks ago in Clinical Trials
South San Francisco, CA -- October 27, 2018 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive results from the Phase II STAIRWAY study which explored the extended durability of faricimab (RG7716) in the treatment of wet age-related macular degeneration (AMD), a leading cause of blindness in people aged 60 and over in the United States.3 At 52 weeks, faricimab patients... Read more
